Mintz Levin - Health Law & Policy Matters

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable…more
| Health

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global…more
| Communications & Media Law, Health, International Law & Trade, Science, Computers, & Technology

Penalties For Health Care Law Violations Surge

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). Through an interim final rule, the…more
| Civil Remedies, Health

California Joins New York and Florida, Passes Out-Of-Network Legislation

Last month the California legislature passed AB-72, which amends the Health & Safety Code to address reimbursement for out of network (OON) providers who provide services at in-network facilities, such as hospitals and…more
| Alternative Dispute Resolution (ADR), Consumer Protection, Health

Law Revamping Medicare ID Cards to Be Revived

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means’ health subcommittee held a hearing on…more
| Health, Science, Computers, & Technology

FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level…more
| Health

Teladoc Receives Support from the Feds

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board’s (the “Board”) appeal was inappropriate and…more
| Antitrust & Trade Regulation, Civil Procedure, Health, Science, Computers, & Technology

Massachusetts Regulatory Overhaul: Hospitals, Clinics, Dialysis Units, and Medical Marijuana – Oh My!

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center…more
| Administrative Law, Health

September Privacy and Security Updates

Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for Civil…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

CMS Proposes Flexible Reporting Under MACRA

In a blog post last week, CMS acting administrator Andy Slavitt said that physicians will have the ability to choose among several options to report data to Medicare under the new physician payment system ushered in by the…more
| Health

2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years. With several insurers…more
| Health, Insurance, Science, Computers, & Technology

GAO Report Suggests Discount Coupons Impact Medicare Spending for Part B Drugs

Last month, the U.S. Government Accountability Office (GAO) released a report in which it found that manufacturer drug coupon programs for privately insured patients could potentially cause the Medicare Part B program to…more
| Health, Science, Computers, & Technology

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical…more
| Constitutional Law, Consumer Protection, Health, Science, Computers, & Technology

FDA Approves Third Biosimilar Product

As we predicted in a previous post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its Arthritis…more
| Health, Science, Computers, & Technology

Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products – GP2015,…more
| Health, Science, Computers, & Technology
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